Biogen Inc. (Nasdaq: BIIB) – Biogen announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to felzartamab, an investigational anti-CD38 monoclonal antibody. This designation is for the treatment of late antibody-mediated rejection (AMR) in kidney transplant patients, specifically in cases without T-cell mediated rejection. The FDA offers BTD to drug candidates aimed at serious or life-threatening conditions that show preliminary clinical evidence of substantial improvement over existing therapies. This designation opens additional avenues for collaboration with the FDA and facilitates the drug development process through Fast Track designation features.
The clinical development data supporting this designation were published in the New England Journal of Medicine and presented as a late-breaking abstract at the 61st European Renal Association (ERA) Congress held in Stockholm in May 2024.
“Antibody-mediated rejection is a significant cause of kidney transplant failure, and patients suffering from AMR currently face a substantial unmet medical need,” stated Travis Murdoch, Head of HI-Bio at Biogen. “We are committed to addressing this critical challenge, and the Breakthrough Therapy Designation will allow us to collaborate efficiently with the FDA to expedite the development of felzartamab for AMR.”
Felzartamab has previously received BTD and Orphan Drug Designation (ODD) from the FDA for its potential in treating primary membranous nephropathy (PMN) and also ODD for AMR in kidney transplant recipients. Phase 2 studies have been completed for AMR, PMN, and IgA nephropathy (IgAN). Biogen plans to initiate Phase 3 trials for felzartamab in AMR, IgAN, and PMN in 2025.
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG for multiple myeloma. HI-Bio exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan).
Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.
Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with chronic AMR affecting ~12% of patients that receive kidney transplants annually in the U.S.1 AMR has emerged as the leading cause of late graft loss in kidney transplant recipients. Effective treatment options for chronic AMR are currently limited.2
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